Medicine
Halobetasol propionate 0.05% cream
Halobetasol propionate 0.05% cream is a generic prescription medicine for topical use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20-25°C (68-77°F).
Key facts
- Active ingredient (INN)
- Halobetasol propionate
- Brand
- Sold under the generic name
- Strength
- 0.05%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 15 g, 50 g, 1 tube and 2 more
- Manufacturers
- Cosette PharmaceuticalsPadagis Israel PharmaceuticalsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D07AC21 Halobetasol propionate
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 July 2007
- Identifiers
- RxCUI 977990DailyMed set ID df26430c-8182-4d03-a254-06d913de4c95, e408184b-0545-4728-9f95-90d8cdec544a, 1f57aaae-8d5f-bfdf-08d6-495b84221311NDC 45802-129, 72162-2331, 0713-0640Application ANDA077123, ANDA078162
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 15 g in 1 tube | 0713-0640-15 | Cosette Pharmaceuticals | 16 July 2007 |
| 50 g in 1 tube | 0713-0640-86 | Cosette Pharmaceuticals | 16 July 2007 |
| 1 tube in 1 carton / 50 g in 1 tube | 45802-129-32 | Padagis Israel Pharmaceuticals | 4 August 2008 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-129-35 | Padagis Israel Pharmaceuticals | 4 August 2008 |
| 1 tube in 1 carton / 50 g in 1 tube | 72162-2331-2 | Bryant Ranch Prepack | 18 June 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 December 1990 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Halobetasol propionate
Clinical summary
Halobetasol propionate is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. It is available as ointment, cream and lotion for topical use. MedsAcross supplies Halobetasol propionate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Halobetasol propionateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Halobetasol Propionate prescribing information (Coral Way Pharma) · U.S. National Library of Medicine, DailyMed
Need Halobetasol propionate 0.05% cream for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.